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News about "National Medical Products Administration (NMPA)"
China Approves Jaypirca for Relapsed CLL and SLL Patients
Jaypirca (pirtobrutinib) by Innovent Biologics has been approved in China for the treatment of adults with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). The BTK inhibitor is designed to overcome resistance associated with prior covalent BTK therapies.
National Medical Products Administration (NMPA) | 02/03/2026 | By News Bureau
China Approves Trelegy Ellipta for Uncontrolled Asthma
China has approved Trelegy Ellipta for adults with uncontrolled asthma, extending its use beyond COPD and making it the only single-inhaler triple therapy for both conditions in the country.
National Medical Products Administration (NMPA) | 27/01/2026 | By News Bureau | 161
Innovent's PECONDLE Becomes China's First Approved IL-23p19 Antibody
Innovent has received NMPA approval for PECONDLE (picankibart injection), marking China’s first IL-23p19 monoclonal antibody to be cleared for treating moderate-to-severe plaque psoriasis in adults eligible for systemic therapy.
National Medical Products Administration (NMPA) | 02/12/2025 | By Dineshwori | 236
Zydus Lifesciences Receives USFDA Tentative Nod for Generic Multiple Sclerosis Drug
Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Diroximel Fumarate delayed-release capsules, 231 mg, a generic version of Vumerity delayed-release capsules of the same strength.
National Medical Products Administration (NMPA) | 13/11/2025 | By Dineshwori | 370
Glenmark Secures China's Approval For RYALTRIS
Glenmark Pharmaceuticals has received regulatory approval in China for RYALTRIS. Combining olopatadine hydrochloride and mometasone furoate, it offers dual-action relief from nasal symptoms, further strengthening Glenmark’s position as a global leader in respiratory innovation.
National Medical Products Administration (NMPA) | 11/11/2025 | By Dineshwori | 359
Akeso's Ivonescimab Wins 4th Breakthrough Therapy Nod in China for TNBC
Akeso has secured its fourth Breakthrough Therapy Designation (BTD) in China for Ivonescimab, targeting first-line treatment of triple-negative breast cancer (TNBC). The ongoing Phase III HARMONi-BC1 trial is assessing its safety and efficacy in this hard-to-treat cancer type.
National Medical Products Administration (NMPA) | 03/11/2025 | By Dineshwori | 190
Anbenitamab Set to Lead as First Bispecific mAb in China's HER2+ Gastric Cancer Market: GlobalData
China’s NMPA has accepted Alphamab Oncology’s NDA for KN026 (Anbenitamab), which could become the first bispecific mAb for HER2-positive gastric and GEJ cancer, according to GlobalData.
National Medical Products Administration (NMPA) | 25/09/2025 | By Dineshwori | 266
NMPA Clears Zhimeng Biopharma's Drug for Phase-II Epilepsy Trial
Zhimeng Biopharma’s drug for Phase II epilepsy trial will be evaluated in a randomized, double-blind, placebo-controlled multinational study to test its efficacy, safety, and tolerability as an adjunct therapy in adults with focal epilepsy.
National Medical Products Administration (NMPA) | 13/09/2025 | By Dineshwori | 172
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